Evaluation of Effectiveness and Safety of Ultimaster Stent in Routine Clinical Practice; A Multicenter, Prospective, Observational Study

초록

Background A third-generation drug-eluting stent using a biodegradable polymer and eluting sirolimus (Ultimaster, Terumo) has been introduced to overcome long-term adverse vascular events, such as restenosis or stent thrombosis. In the present study, we aimed to evaluate 12-month clinical outcomes of Ultimaster stent for coronary artery disease patients. Methods A total of 576 patients were enrolled in a multicenter, prospective, observational registry at 12 hospitals. To represent real-world clinical practice, almost all subtypes of patients and lesions were included in this study. The study endpoint was major adverse cardiac events (the composite of total death, recurrent myocardial infarction, and target vessel revascularization) at 12-month clinical follow-up. Results Most patients were male (76.5%), with a mean age of 66.0 ± 11.2 years. Diabetes mellitus was present in 40.1%, and 67.9% presented with acute coronary syndromes (ACS). At 12 months, the incidence of total death was 2.2%, recurrent myocardial infarction 1.0%, repeat revascularization 3.9% (target lesion revascularization 2.7%, target vessel revascularization 3.1%), stent thrombosis 0.6%, and major adverse cardiac events 6.2%. With regard to lesion-based outcome, target lesion failure (cardiac death, recurrent myocardial infarction, and target lesion revascularization) occurred in only 4.1%. In subgroup analysis according to the presence of ACS, diabetes mellitus, hypertension, dyslipidemia, and bifurcation, there was no major differences in the incidence of individual and composite hard endpoints except higher a incidence of repeat revascularization in the ACS group. Conclusions The present registry shows that the sirolimus-eluting, bioresorbable-polymer Ultimaster stent is safe and effective in daily clinical practice, with a low rate of major adverse cardiac events up to 12 months.